GMP Material Scientist for synthetic manufacturing platforms
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Bagsværd
Are you a skilled GMP material scientist with good understanding of organic synthesis and/or chemical manufacturing, and want to use your GMP material handling expertise to support the growth of our synthetic manufacturing platforms? Then you could be our new colleague in Emerging Technologies API Manufacturing Development (ET API MDev) Bagsværd. Apply now and start your new journey!
ET API MDev is part of CMC Chemical Developmt - get introduced to our area and meet some of our employees by visiting our career site The position The position as GMP Material Scientist is anchored in Emerging Technologies API Manufacturing Development, which oversees our synthetic processes for commercial production of synthetic peptides, small molecules, and oligonucleotides as well as some of the building blocks used in semi-recombinant API processes. We are looking for a GMP Material Scientist (Job seniority depending on the experience of the candidate) with good understanding of the regulatory requirements and processes for handling of GMP materials internally and at external contract manufacturing organizations. The preferable candidate is experienced in handling of GMP materials, herein critical raw materials, customized building blocks, API starting materials and bulk pharmaceutical chemicals. Knowledge of organic synthesis and experience with material handling within the chemical manufacturing areas is a strong advantage. Your main task will include the following: Support to standardize the requirements and processes for the handling of customized chemical building blocks (herein API Starting Materials) across the synthetic manufacturing platforms Support the establishment of adequate control strategy for the raw materials and regulatory starting materials used in the API processes internally or at the contract manufacturing organizations Active scientific evaluation of changes and deviations related to raw materials together with API product and process responsibles Support the authoring and review of documentation and risk assessments for raw materials and starting materials Be our subject matter expert for GMP material handling in the department Handling urgent issues with the materials with high impact for their use in processes This job gives you a unique opportunity to work with multiple stakeholders including Late-Stage Development, Analytical Functions, Global Contract Manufacturing (GCM), QA, RA, Sourcing, pilot facilities, production facilities, and external partners. Some travel activities can be expected. The position does not involve practical work in the laboratory. Qualifications To succeed in the role, we expect that you have some of the below qualification and is eager to learn any remaining required skillset: Ph.D. or M.Sc. in organic chemistry, chemical engineering, or equivalent. Experience with handling and control of raw materials and regulatory starting materials Experience with chemical manufacturing platforms is a strong advantage Relevant GMP experience and understanding of GMP requirements for synthetic APIs or bulk pharmaceutical chemicals is a strong advantage Knowledge of ICH guidelines relevant for API development, manufacturing, and control. As a person, you possess a solution-oriented mindset with a strong practical capability to convert theoretical knowledge into practical solutions for technical challenges. Your ability to communicate and collaborate effectively with internal and external stakeholders across different disciplines in both development and production is highly valuable. Your positive attitude enables you to work efficiently, whether as a team player or independently, on complicated tasks, ensuring timely progress. About the department As part of Novo Nordisk’s Product Supply organization, you will be assigned to ET API MDev, a cross-functional area currently being established within Chemistry, Manufacturing & Control (CMC) Development & Scaling area. We work at the interface between CMC and full-scale manufacturing with a focus on process understanding, implementation, optimization, and life cycle management.
We offer a very interesting and varying job with the opportunity to work with other highly qualified and motivated colleagues in a multidisciplinary project environment. Working at Novo Nordisk At Novo Nordisk, we don’t wait for a change. We drive it. We’re a dynamic company in an even more dynamic industry, and we know that what got us to where we are today is not necessarily what will make us successful in the future. We embrace the spirit of experimentation, striving for excellence without fixating on perfection. We never shy away from opportunities to develop, we seize them. From research and development to manufacturing, marketing, and sales – we’re all working to move the needle on patient care. Contact For further information, please contact Hao Jiang at +45 3448 4222. Deadline Feb 28th, 2024. Applications are reviewed on an ongoing basis, so please submit your application as soon as possible. You do not need to attach a cover letter to your application, but please include a few sentences about why you are applying in your resume or CV. To ensure an efficient and fair process, please refrain from adding a photo to your CV. We commit to an inclusive recruitment process and equality of opportunity for all our job applicants. At Novo Nordisk we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we’re life changing.
ET API MDev is part of CMC Chemical Developmt - get introduced to our area and meet some of our employees by visiting our career site The position The position as GMP Material Scientist is anchored in Emerging Technologies API Manufacturing Development, which oversees our synthetic processes for commercial production of synthetic peptides, small molecules, and oligonucleotides as well as some of the building blocks used in semi-recombinant API processes. We are looking for a GMP Material Scientist (Job seniority depending on the experience of the candidate) with good understanding of the regulatory requirements and processes for handling of GMP materials internally and at external contract manufacturing organizations. The preferable candidate is experienced in handling of GMP materials, herein critical raw materials, customized building blocks, API starting materials and bulk pharmaceutical chemicals. Knowledge of organic synthesis and experience with material handling within the chemical manufacturing areas is a strong advantage. Your main task will include the following:
We offer a very interesting and varying job with the opportunity to work with other highly qualified and motivated colleagues in a multidisciplinary project environment. Working at Novo Nordisk At Novo Nordisk, we don’t wait for a change. We drive it. We’re a dynamic company in an even more dynamic industry, and we know that what got us to where we are today is not necessarily what will make us successful in the future. We embrace the spirit of experimentation, striving for excellence without fixating on perfection. We never shy away from opportunities to develop, we seize them. From research and development to manufacturing, marketing, and sales – we’re all working to move the needle on patient care. Contact For further information, please contact Hao Jiang at +45 3448 4222. Deadline Feb 28th, 2024. Applications are reviewed on an ongoing basis, so please submit your application as soon as possible. You do not need to attach a cover letter to your application, but please include a few sentences about why you are applying in your resume or CV. To ensure an efficient and fair process, please refrain from adding a photo to your CV. We commit to an inclusive recruitment process and equality of opportunity for all our job applicants. At Novo Nordisk we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we’re life changing.
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Denne ledige stilling har jobtypen "Øvrige", og befinder sig i kategorien "Øvrige stillinger".
Arbejdsstedet er beliggende i Bagsværd.
Jobbet er oprettet på vores service den 7.2.2024, men kan have været deaktiveret og genaktiveret igen.
Dagligt opdateret: Dette job opdateres dagligt ud fra jobudbyderens hjemmeside via vores søgemaskineteknologi og er aktivt lige nu.
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